Since stepping in as Sanofi’s CEO in April, Belén Garijo has launched a deep look at the pharma’s pipeline, reassessing assets based on “scientific merit” and potential for long-term value in the quest for a Dupixent follow-up.
Sanofi has suspended a Phase 2 study testing an investigational antibody in non-cystic fibrosis bronchiectasis, as new CEO Belén Garijo reassesses the company’s pipeline.
The pause was driven by “strategic business reasons to facilitate internal portfolio review,” and not because of the asset’s safety or benefit/risk profile, according to a federal clinical trials database.
The asset in question is called SAR445399, a monoclonal antibody designed to block the interleukin-1 receptor 3 (IL-1R3), a key player in immune-related signaling cascades. The drug came to Sanofi in December 2015 when the pharma inked a research and license collaboration with MAB Discovery.
Sanofi’s pipeline page lists SAR445399 as under mid-stage development for hidradenitis suppurativa. That study remains open and recruiting as of July 1. Sanofi has no pipeline entry for the asset in non-cystic fibrosis bronchiectasis.
BioSpace has reached out to the pharma for more color on the matter.
Sanofi is amid what Garijo calls a “very rigorous portfolio prioritization process.”
Garijo, who took the reins in April succeeding former chief executive Paul Hudson, revealed this effort during the company’s second quarter earnings call last week, noting that “we are going to look very deeply at our current late-stage portfolio.” The decision to push an asset forward, she said, will depend on “scientific merit, potential to create long-term value and, obviously, ensuring the right risk profile of our pipeline moving forward.”
That same day, Sanofi revealed that it would shelve the IL-33 inhibitor itepekimab, which was being developed for chronic obstructive pulmonary disease. Phase 3 data released in May last year were mixed: itepekimab significantly reduced exacerbations in former smokers with inadequately controlled disease in only one of two late-stage trials.
Sanofi had been positioning itepekimab as a successor to its blockbuster drug Dupixent, which will lose key patent protections in the coming years.
Sanofi also axed the oral TNFR blocker balinatunfib last week, after the asset failed to significantly ease psoriasis severity in a mid-stage study.
Late last month, the pharma also discontinued all but one of its ongoing studies for the investigational antibody amlitelimab after a disappointing showing in a Phase 3 atopic dermatitis trial. Sanofi has also scrapped plans to file for amlitelimab’s approval, which the company had originally scheduled for later this year. Only a celiac disease study of amlitelimab will stay online, with data expected later this year.
Sanofi obtained amlitelimab in its $1.4 billion acquisition of Kymab in 2021. In conjunction with the trial discontinuations, the pharma absorbed a €952 million ($1.1 billion) impairment loss in the second quarter.
